FDA — authorised 31 December 1985
- Application: NDA018735
- Marketing authorisation holder: BRACCO
- Local brand name: ISOVUE-370
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Iopamidol 370 in United States
FDA authorised Iopamidol 370 on 31 December 1985 · 39 US adverse-event reports
Marketing authorisations
FDA — authorised 12 October 1994
- Application: NDA020327
- Marketing authorisation holder: BRACCO
- Local brand name: ISOVUE-370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 April 1997
- Application: ANDA074679
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: IOPAMIDOL-370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 December 1997
- Application: ANDA074898
- Marketing authorisation holder: HOSPIRA
- Local brand name: IOPAMIDOL-370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 1998
- Application: ANDA075005
- Marketing authorisation holder: HOSPIRA
- Local brand name: IOPAMIDOL-370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 2000
- Application: ANDA074881
- Marketing authorisation holder: COOK IMAGING
- Local brand name: IOPAMIDOL-370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 39
Most-reported reactions
- Nausea — 6 reports (15.38%)
- Dyspnoea — 5 reports (12.82%)
- Loss Of Consciousness — 5 reports (12.82%)
- Cardio-Respiratory Arrest — 4 reports (10.26%)
- Erythema — 4 reports (10.26%)
- Arteriospasm Coronary — 3 reports (7.69%)
- Cerebral Infarction — 3 reports (7.69%)
- Chest Pain — 3 reports (7.69%)
- Feeling Abnormal — 3 reports (7.69%)
- Rash Generalised — 3 reports (7.69%)
Iopamidol 370 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Iopamidol 370 approved in United States?
Yes. FDA authorised it on 31 December 1985; FDA authorised it on 12 October 1994; FDA authorised it on 2 April 1997.
Who is the marketing authorisation holder for Iopamidol 370 in United States?
BRACCO holds the US marketing authorisation.